Expired calibration of infusion/drivers
I'm looking for information on expired calibration of infusion/drivers. If an infusion/driver had a service/calibration sticker stating should not be used after April 2019 and was being used in an intensive care unit to keep a person alive would this breach the regs or SOP
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Yes, it is a violation of both the regulations and the SOP.
For more information about calibration, please read this article:
Calibration requirements in ISO 13485“ https://advisera.com/13485academy/blog/2019/03/08/calibration-requirements-in-iso-13485/
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Oct 30, 2019